ReviewJournal of postgraduate medicine
Pharmacovigilance of biosimilars - Why is it different from generics and innovator biologics?
Review in Journal of postgraduate medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Anti-vascular endothelial growth factor biosimilars for neovascular age-related macular degeneration.The Cochrane database of systematic reviews · 2024Pooled it
- Use of Biosimilars: A Systematic Review of Published Position Statements and Recommendations from Health Organisations and Societies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024Pooled it
- Drug Utilization Study and Safety Pattern of Biologicals in a Tertiary Care Hospital at Eastern India.Cureus · 2026Article
- Adverse Events in Patients with Inflammatory Bowel Disease Treated with Advanced Therapies: A Nationwide, Population-Based, Propensity-Matched Cohort Study.Journal of clinical medicine · 2026Article
- Anti-vascular endothelial growth factor (anti-VEGF) agents for neovascular age-related macular degeneration (nAMD): a network meta-analysis.The Cochrane database of systematic reviews · 2026Article
- Recommendations for Interchangeability in a Growing Biosimilar Market in Latin America.Advances in therapy · 2024Review
- Generic orphan drug substitution: a critical analysis of global practices and Saudi Arabia's perspective.Frontiers in pharmacology · 2024Article
- Knowledge, Attitudes and Practice of Healthcare Providers, Healthcare Regulatory Practitioners and Patients Toward Biosimilars in China: Insights From a Nationwide Survey.Frontiers in pharmacology · 2022Article
- Clinical and Regulatory Concerns of Biosimilars: A Review of Literature.International journal of environmental research and public health · 2020Review
- Pharmacovigilance of biosimilars - Why is it different from generics and innovator biologics?Journal of postgraduate medicineArticle
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Biosimilars are being marketed in India since 2000. Like biologics, biosimilars have a large size, complex structure, and complicated manufacturing process, and they are produced in a living organism. It requires specialized delivery devices for administration and needs tighter temperature control to prevent degradation. As biosimilar development follows abbreviated pathway, adverse events (AEs) previously unknown during a clinical trial may be detected postmarketing. In India, the awareness on pharmacovigilance has increased significantly after implementation of the pharmacovigilance guidance in January 2018. However, biologics require tighter monitoring to ensure their safety and efficacy. This review article discusses the importance of pharmacovigilance for biosimilars, how it is different from generics, and provides recommendations to sensitize clinicians and researchers about the requirement of a different approach to improve pharmacovigilance for biosimilars. Pharmacovigilance for biosimilars is as important as it is for innovator biologics and more important than that for generics.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.